UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation on usefulness and safety of cysto-urethral anastomosis with additional ileal flap in patients with rectal cancer involving the prostate
Acronym	Ileal flap study
Scientific Title	Evaluation on usefulness and safety of cysto-urethral anastomosis with additional ileal flap in patients with rectal cancer involving the prostate
Scientific Title:Acronym	Ileal flap study
Region	Japan

Condition
Condition	Lower rectal cancer involving the prostate
Classification by specialty	Gastrointestinal surgery Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Improvement and prevention of cysto-urethral anastomotic leakage. Safety of additional flap operation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cysto-urethral anastomotic leak rate at postoperative one month.
Key secondary outcomes	Rate of major leakage in cysto-urethral anastomosis. Healing term of CUA leakage. Safety of flap operation.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Additional ileal flap operation in cysto-urethral anastomosis.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male
Key inclusion criteria	1.Male patients with locally advanced rectal cancer involving the prostate clinically. 2.Pathological proven adenocarcinoma. 3.Possible to be preservation of the sphincter urethrae. 4.With or Without anus-preservation. 5.No distant metastasis. 6.Normal length of the small intestine. 7.Aged 20 to 75 years old. 8.PS(ECOG) of 0 or 1. 9.Enough organ functions. WBC count : >=3000/mm3 Platelet count : >=70000/mm3 Hemoglobin : >=8.0g/dl T-Bil : <=1.5mg/dl AST : <=100IU/l ALT : <=100IU/l Cr : <=1.5mg/dl Alb : >=2.8g/dl 10. With or Without previous radiotherapy and chemotherapy. 11. Writhen informed consent.
Key exclusion criteria	1. Patients with request of total pelvic exenteration (TPE), or patients without request of the ileal flap operation. 2. Impossible to be curative resection. 3. Patients with serious disease as follows. Uncontrollable diabetes mellitus(Hba1c >=8%) renal failure requiring artificial dialysis. requiring immunosuppressants 4. Patients with serious organ failure. 5. Cannot agree on this study. 6. Unsuitable patients for this study.
Target sample size	12

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Norio Saito
Organization	National Cancer Center Hospital East
Division name	Colorectal and Pelvic Surgery
Zip code
Address	6-5-1, Kashwanoha, Kashiwa, 277-8577, Japan
TEL	04-7133-1111
Email	norsaito@east.ncc.go.jp

Public contact
1st name of contact person	1st name Middle name Last name Norio Saito
Organization	National Cancer Center Hospital East
Division name	Colorectal and Pelvic Surgery
Zip code
Address	6-5-1, Kashwanoha, Kashiwa, 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	norsaito@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立がん研究センター東病院（千葉県） 愛知県がんセンター中央病院(愛知県）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 13 Day
Date of IRB	2013 Year 03 Month 04 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2014 Year 09 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 04 Month 18 Day
Last modified on	2019 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012313